Associate Clinical Research Manager (aCRM) - Infectious Disease (REMOTE)

Merck KGaA Darmstadt Germany - Dover, DE

Full-time - Mid Level

Remote - Dover, DE

Chemical Manufacturing

About the position

The Associate Clinical Research Manager (aCRM) for Infectious Disease at Merck is a pivotal role that involves comprehensive project management and oversight of clinical trials within a designated country. This position is responsible for ensuring that all assigned protocols are executed in compliance with ICH/GCP guidelines, local regulations, and company policies. The aCRM serves as the main point of contact for assigned protocols, acting as a crucial link between Country Operations and the Clinical Trial Team (CTT). This role requires a proactive approach to planning, driving, and tracking the execution of deliverables, timelines, and results to meet country commitments from the feasibility stage through to site selection, recruitment, execution, and closeout of studies. In this role, the aCRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements. Responsibilities include reviewing monitoring visit reports, escalating performance issues, and conducting quality control visits as necessary. The aCRM leads local study teams, providing training on protocols and collaborating closely with Clinical Research Associates (CRAs) and other local roles to ensure high performance and effective coordination of activities. Additionally, the aCRM is responsible for creating and executing local risk management plans and ensuring compliance with key systems such as CTMS and eTMF. The position also involves building and maintaining strong business relationships with investigators and external partners, supporting local and regional strategy development, and collaborating with various internal functions to align on key issues and decisions across trials. The aCRM must possess strong organizational skills, scientific knowledge, and the ability to communicate effectively in a remote environment, making strategic decisions and managing multiple deliverables simultaneously.

Responsibilities

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies, including planning, driving, and tracking execution and performance of deliverables/timelines/results.
• Accountable for performance for assigned protocols in compliance with ICH/GCP and country regulations, company policies, and quality standards.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance, trains local roles in the protocol, and coordinates activities across different local country roles.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalates challenges and issues to TA-Head/CRD/CCQM and/or CTT as appropriate.
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head, and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials.

Requirements

• Minimum 4 years of experience in clinical research.
• Bachelor degree in Science (or comparable).
• Knowledge in Project Management and/or site management.
• Strong organizational skills with demonstrated success in related role or discipline required.
• Ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments.
• Understanding of local regulatory environment.
• Scientific and clinical research knowledge is required.
• Understanding of clinical trial planning, management, and metrics is essential.
• Ability to function as a key link between Country Operations and Clinical Trial Teams.
• Effective communication skills and ability to build collaboration in a remote/virtual environment.
• Ability to manage processes, productivity, quality, and project delivery.
• Proficiency in written and spoken English and local language.

Nice-to-haves

• CRA experience preferred.